Benefit of a Hospital Intervention in Patients With Hepatic Steatosis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorConsorci Sanitari de l'Alt Penedès i Garraf

About this trial

The objective of this clinical trial is to determine whether a specialized consultation for controlling metabolic syndrome effectively treats hepatic steatosis in adults. The primary questions it aims to answer are:

• Does this specialized consultation increase the number of patients with hepatic steatosis who show improvement after one year of clinical follow-up in said consultation?

The improvement of the disease will be assessed through the following parameters:

* liver laboratory tests * weight loss * improvement in cholesterol and triglyceride levels. Researchers will compare follow-up in the specialized consultation to standard follow-up to assess the effectiveness of the specialized consultation in treating hepatic steatosis.

Participants will be randomly assigned to two groups. The first group will be visited in the specialized consultation every three months for one year and will continue to receive the rest of their follow-up visits. The second group will undergo their usual follow-up visits but will not be visited in the specialized consultation.

Eligibility criteria

Qualifiers

Patients seen in outpatient gastroenterology clinics with hepatic steatosis.

Diagnosed with hepatic steatosis through ultrasound or abdominal CT scan

Mild to moderate fibrosis as assessed by elastography or FibroScan (F1-F3) or with a Fibrosis-4 (FIB-4) Index less than 3.5.

Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.

Disqualifiers

Patients who do not have any hepatic imaging test conducted in the last 5 years.

Conditions other than hepatic steatosis requiring gastroenterological follow-up.

Abusive alcohol consumption, defined as weekly intake of > 50 g in women and more than 70 g in men.

Cognitive or affective disorders limiting the ability to cooperate with study procedures.

Trial design

Treatments tested in this trial

  • Specialized Unit
  • Usual Follow-Up

Treatment groups

86 Participants
are divided into 2 treatment groups